Breast Cancer
Conditions
Keywords
Real-World Evidence, Unresectable Breast Cancer, Metastatic Breast Cancer, HER2+, HER2-low, Observational, non-interventional
Brief summary
This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) \[globally\] or HER2-low \[North America only\] in routine clinical practice.
Detailed description
This is a multi-center, observational prospective study that will characterize the demographic and clinical characteristics, treatment patterns, effectiveness, tolerability and its management, and patient experience of Trastuzumab Deruxtecan (T-DXd) in a real-world setting. This study is planned to be conducted in several countries and aims to enroll approximately 750 patients eligible patients with HER2+ unresectable and/or metastatic breast cancer (mBC) who has received a prior anti HER2 based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and has developed disease recurrence during or within 6 months of completing therapy. Approximately 250 eligible patients with HER2-low unresectable and/or mBC who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy will be enrolled into the study in North America only. The planned duration of patient recruitment is approximately 18 months for HER2+ and approximately 12 months for HER2 low.
Interventions
OTHERNone (Observational Study)
Not Applicable since observational study
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years of age at time of consent. * Histological or cytological confirmed diagnosis of unresectable and/or mBC. * Documented HER2 status via a validated method. * Adult patients with unresectable or metastatic HER2+ breast cancer who have received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing therapy. Or Adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. * Decision to newly initiate monotherapy T-DXd per standard of care. * Capable of providing informed consent and completing questionnaires.
Exclusion criteria
* Pregnancy or breastfeeding. * History of other primary malignancies in 2 years prior to unresectable and/or mBC diagnosis. * Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-World Time to Next Treatment (rwTTNT) | From first dose of T-DXd until study discontinuation (approximately 3 years) | Real-world time to next treatment will be evaluated. rwTTNT is defined as the length of time from date of first T-Dxd administration to the date the patient received an administration of their next systemic treatment regimen or to their date of death if there is a death prior to having another systemic treatment regimen. |
| T-Dxd treatment patterns for HER2+ cohort | Approximately 3 years | Treatment patterns will be summarised using summary statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Physician reported Safety Events of Interest (SEIs) | From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration) | The safety and tolerability of T-Dxd through the collection of physician-reported SEIs will be assessed. |
| Number of patients provided prophylactic and reactive treatment for SEIs management | From first dose of T-DXd until End of T-DXd treatment (40 + 7 days after last T-DXd administration) | The management of SEIs will be characterized. |
| Real-World Time to Discontinuation (rwTTD) | From first dose of T-DXd until study discontinuation (approximately 3 years) | Real-World Time to Discontinuation of T-DXd will be evaluated. rwTTD is defined as time from index date to the earliest date of T-DXd discontinuation, or death. |
| T-Dxd treatment patterns for HER2-low | Approximately 3 years | Treatment patterns will be summarised using summary statistics. |
| Symptomatic SEI as measured by selected items from National Cancer Institute Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) | Approximately 3 years | Patient-reported tolerability will be evaluated by selected items from the NCI PRO-CTCAE. The following items are selected: nausea, vomiting, bloating of the abdomen, shortness of breath, cough, heart palpitations, hair loss, and fatigue, tiredness or lack of energy. |
| Daily Nausea and Vomiting symptom diary | From first dose of T-DXd until 3 months | Nausea and vomiting symptoms diary will be assessed based on severity, interference with appetite and usual activities. |
| Patient-reported overall side effect burden as measured by the Patient's Global Impression of Treatment Tolerability (PGI-TT) | Approximately 3 years | Patient-reported tolerability will be evaluated by PGI-TT. Single question asking patients how bothered they were by the side effects of their cancer treatment, ranging from Not at all to Very much. |
| Demographics and clinical charcteristics | At Baseline (14 to 30 days prior to T-DXd initiation) | Summary statistics will be used to describe the Demographics and clinical characteristics |
Countries
Austria, Brazil, Canada, Israel, Italy, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed